A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)

NCT07242248 | Recruiting DMC

• 1 other identifier: CNTO1959IBD4006
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the clinical effectiveness (how well the treatment works) of Guselkumab, by lines of treatment and subpopulations, and what are the outcomes of treatment (clinical outcomes) in adult participants with moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD) under real-world settings. CD and UC are the main type of Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.

Conditions

Colitis, Ulcerative; Inflammatory Bowel Disease; Crohn's Disease

Outcome Measures

Primary Outcomes (10)

• Number of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI)

  HBI score is used to assess disease severity and treatment effectiveness. The HBI consists of a 5-part questionnaire, assessing general wellbeing, abdominal pain, number of liquid stools per day, abdominal mass and complications. Clinical remission for CD is defined as the HBI score less than or equal to (\<=) 4.

  Up to Week 96

• Number of Participants Achieving Clinical Remission for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS)

  Mayo scoring system is used to assess disease severity and treatment effectiveness. Clinical remission for UC is defined as the PMS score \<=2 and a rectal bleeding subscore of 0.

  Up to Week 96

• Number of Participants Achieving Clinical Response for CD as Measured by HBI

  HBI score is used to assess disease severity and treatment effectiveness. The HBI consists of a 5-part questionnaire, assessing general wellbeing, abdominal pain, number of liquid stools per day, abdominal mass and complications. Clinical response for CD is defined as the HBI score less than or equal to (\<=) 4 or a decrease by greater than or equal to (\>=) 3.

  Up to Week 96

• Number of Participants Achieving Clinical Response for UC as Measured by PMS

  Mayo scoring system is used to assess disease severity and treatment effectiveness. Clinical response for UC is defined as the PMS \<4 or \>=30 percent (%) reduction of baseline PMS.

  Up to Week 96

• Number of Participants Achieving Corticosteroid-free Remission for CD as Measured by HBI

  Corticosteroid-free remission for CD is defined as no use of steroids for at least 30 days and HBI score \<=4. HBI score is used to assess disease severity and treatment effectiveness.

  Up to Week 96

• Number of Participants Achieving Corticosteroid-free Remission for UC as Measured by PMS

  Corticosteroid-free clinical remission for UC is defined as no use of steroids for at least 30 days and PMS \<2 and a rectal bleeding subscore of 0. Mayo scoring system is used to assess disease severity and treatment effectiveness.

  Up to Week 96

• Number of Participants Achieving Corticosteroid-free Clinical Response for CD as Measured by HBI

  Corticosteroid-free clinical response for CD is defined as no use of steroids for at least 30 days and a reduction in HBI score by \>=3 points from baseline or achieving HBI score \<=4. HBI score is used to assess disease severity and treatment effectiveness.

  Up to Week 96

• Number of Participants Achieving Corticosteroid-free Clinical Response for UC as Measured by PMS

  Corticosteroid-free clinical response for UC is defined as no use of steroids for at least 30 days and PMS \<4 or \>=30% reduction from baseline. Mayo scoring system is used to assess disease severity and treatment effectiveness.

  Up to Week 96

• Number of Participants Achieving Patient-Reported Outcome (PRO)-2 Corticosteroid-Free Remission for CD as Measured by HBI

  Participants with corticosteroid-free remission by PRO-2 will be assessed. An abdominal pain (AP) score \<=1 and a mean stool frequency (SF) score \<=3 and no worsening of AP or SF compared with baseline and no use of corticosteroids for at least 30 days will be defined as a PRO-2 corticosteroid-free remission.

  Up to Week 96

• Number of Participants Achieving PRO-2 Corticosteroid-Free Remission for UC as Measured by PMS

  Participants with corticosteroid-free remission by PRO-2 will be assessed. An SF score of 0 or 1, where it has not increased from baseline, and a rectal bleeding score of 0 with no use of corticosteroids for at least 30 days will be defined as a corticosteroid-free PRO-2 remission.

  Up to Week 96

Secondary Outcomes (41)

• Number of Participants with Early Responses to Guselkumab Measured Using PRO-2 Components for UC

  Baseline (at Week 0), Weeks 1, 2, 4, 8, 12

• Number of Participants with Early Responses to Guselkumab Measured Using PRO-2 Components for CD

  Baseline (at Week 0), Weeks 1, 2, 4, 8, 12

• Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency

  Baseline (at Week 0), Weeks 1, 2, 4, 8, 12

• Time to Guselkumab Persistence

  Up to Week 96

• Characteristics of Participants Receiving Guselkumab Treatment: Age

  At Baseline

Study Arms (1)

Group 1: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD)

Participants with confirmed diagnosis of moderate-to-severe UC or CD treated with guselkumab as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available from standard clinical practice and medical records will be collected.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include participants with confirmed diagnosis of moderate-to-severe Crohn's disease (CD) or Ulcerative colitis (UC) disease.

You may qualify if:

• Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of the drug. Decision to prescribe must solely be made by the treating physician in line with the Trust's/ Health Board's treatment guidance. Enrolment must take place before or at the day of first administration (but after treatment decision by physician)
• Must have a confirmed diagnosis of moderate-to-severe Crohn's Disease (CD) or Ulcerative Colitis (UC) recorded in their medical records
• Must sign a informed consent form (ICF) allowing source data verification in accordance with local requirements

You may not qualify if:

• Contraindicated to guselkumab per the label
• Is currently enrolled in an interventional clinical study
• Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya® (guselkumab), Skyrizi ® (risankizumab) and Omvoh® (mirikizumab). As an exception, participants with history of ustekinumab exposure, may be included
• Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and /or small molecules)
• Is unable to provide informed consent

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

Study Sites (1)

London North West University Healthcare NHS Trust

Harrow, HA1 3UJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Janssen-Cilag Limited Clinical Trial

  Janssen-Cilag Limited

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): March 5, 2029
• Study Completion (Estimated): March 17, 2029
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)